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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01048853
Registration number
NCT01048853
Ethics application status
Date submitted
12/01/2010
Date registered
14/01/2010
Date last updated
12/04/2024
Titles & IDs
Public title
Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer
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Scientific title
Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer
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Secondary ID [1]
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NCI-2012-01254
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Secondary ID [2]
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2008-0118
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical Adenocarcinoma
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Cervical Squamous Cell Carcinoma, Not Otherwise Specified
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Stage IA2 Cervical Cancer AJCC v6 and v7
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Stage IB1 Cervical Cancer AJCC v6 and v7
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Lymph Node Mapping
Other interventions - Quality-of-Life Assessment
Treatment: Surgery - Salpingo-Oophorectomy
Treatment: Surgery - Sentinel Lymph Node Biopsy
Treatment: Surgery - Therapeutic Conventional Surgery
Experimental: Treatment (conservative surgery) - Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.
Treatment: Surgery: Lymph Node Mapping
Undergo lymphatic mapping with sentinel lymph node biopsy
Other interventions: Quality-of-Life Assessment
Ancillary studies
Treatment: Surgery: Salpingo-Oophorectomy
Undergo hysterectomy with or without salpingo-oophorectomy
Treatment: Surgery: Sentinel Lymph Node Biopsy
Undergo lymphatic mapping with sentinel lymph node biopsy
Treatment: Surgery: Therapeutic Conventional Surgery
Undergo hysterectomy with or without salpingo-oophorectomy
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility of study treatment by determining the immediate failure rate, defined as residual disease in the sample hysterectomy specimen
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Assessment method [1]
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The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%.
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Timepoint [1]
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Up to 7 days
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Primary outcome [2]
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Recurrence rate
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Assessment method [2]
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Will estimate with an exact 95% binomial confidence interval.
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Timepoint [2]
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2 years
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Primary outcome [3]
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Short Form Health Survey SF-12 Questionnaires
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Assessment method [3]
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Will summarize each of the quality of life instruments (12-Item Short Form Health Survey [SF12], using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval.
Short Form Health Survey SF-12: This 12-item questionnaire was developed from the longer SF-36. Scale Score (Excellent 1 Very Good 2 Good 3 Fair 4 , Poor 5)The SF-12 estimates each of eight health domains (physical functioning, role-physical, role-emotional, mental health, bodily pain, vitality, social functioning and general health) using a tool that takes less than 2 minutes to administer. Scores are given in each domain as well as summary scores for overall physical and mental status. Empirical cross-validation studies have shown correlations between the SF-12 and SF-36 surveys ranging from 0.93 to 0.97 [23]
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Timepoint [3]
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Baseline up to 5 years
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Primary outcome [4]
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Functional Assessment of Cancer Therapy-Cervix [FACT-CX] Questionnaires
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Assessment method [4]
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Will summarize each of the quality of life instruments Functional Assessment of Cancer Therapy-Cervix [FACT-CX] using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval.
Functional Assessment of Cancer Therapy (FACT-CX): The FACT-G is the generic score to measure quality of life for patients with cancer. This instrument contains 27 questions from 4 domains: physical well-being, social/family well-being, emotional well-being, and function well-being. Scale Score ( Not at all 0- A little bit 1, Somewhat 2, Quite a bit 3, Very Much 4)The FACT instruments are well regarded particularly because several disease specific subscales exist, including cervix cancer (FACTCX). The cervix cancer subscale consists of 15 questions pertaining to patients with cervix cancer. The FACT-CX should take about 5 minutes to complete.
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Timepoint [4]
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Baseline up to 5 years
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Primary outcome [5]
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MD Anderson Symptom Inventory MDASI Questionnaires
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Assessment method [5]
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Will summarize each of the quality of life instruments MD Anderson Symptom Inventory [MDASI], using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval.
MD Anderson Symptom Inventory (MDASI): The MD Anderson Symptom Inventory (MDASI) is a 19-item questionnaire. The first 13 items assess patient symptoms during the prior 24 hours and should take less than 3 minutes to complete. Scale Score(Not Present 0-10 Bad as you can imagine) Symptoms assessed include pain, fatigue, nausea/vomiting, anorexia, sleep symptoms, and distress. The last 6 items assess how those symptoms have interfered with the patient's general well-being, including their general activity, mood, ability to walk and perform normal work, as well as their relationships with others and enjoyment of life. The validity and reliability of the MDASI have been well-established [24].
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Timepoint [5]
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Baseline up to 5 years
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Primary outcome [6]
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Female Sexual Functioning Index (FSFI) Questionnaires
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Assessment method [6]
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Will summarize each of the quality of life instruments Female Sexual Functioning Index [FSFI]) using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval.
Female Sexual Functioning Index (FSFI): Sexual functioning will be assessed using the Female Sexual Function Index (FSFI), a 19-item multiple-choice survey that takes approximately 5 minutes to complete [25]. The questionnaire measures sexual desire, arousal (both subjective and physiological), lubrication, orgasm, satisfaction, and pain. Validation studies on sexually dysfunctional and matched control women aged 21 to 70 have demonstrated excellent internal consistency (0.89 to 0.97) and 2 to 4 week test-retest reliability (0.79 to 0.88) for each subscale [25
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Timepoint [6]
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Baseline up to 5 years
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Primary outcome [7]
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Satisfaction with Decision(SWD)Scale Questionnaires
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Assessment method [7]
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Will summarize each of the quality of life instruments Satisfaction with Decision(SWD)Scale using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval.
Satisfaction with Decision (SWD) Scale: The Satisfaction with Decision scale is a six-item survey that measures the patient's satisfaction with health care decisions. The instrument has been shown to have excellent reliability and validity [26].
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Timepoint [7]
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Baseline up to 5 years
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Primary outcome [8]
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Proportion of patients identified with metastases present, micrometastases present, isolated tumor cells, and tumor absent in sentinel lymph nodes
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Assessment method [8]
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Will classify each patient as having metastases present, micrometastases present, isolated tumor cells present, or no tumor present according to the histopathology of the sentinel lymph nodes. Will tabulate the number and percent of patients in each of these 4 categories. Will estimate the proportion of patients identified with metastases present, micrometastases present, isolated tumor cells, and tumor absent with 95% confidence intervals.
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Timepoint [8]
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Up to 5 years
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Eligibility
Key inclusion criteria
- Histologically confirmed squamous cell carcinoma of the cervix (any grade) or
histologically confirmed grade 1 or 2 adenocarcinoma of cervix
- International Federation of Gynecology and Obstetrics (FIGO) stage IA2 or IB1 disease
- Tumor diameter =< 2 cm on physical exam and on imaging studies
- No lymphovascular space invasion (LVSI) present on biopsy or previous cone
- Less than 10 mm of cervical stromal invasion
- Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer,
cervical intraepithelial neoplasia (CIN) II, CIN III or adenocarcinoma-in-situ; (a
negative margin is defined as no invasive cancer within 1.0 mm of both the
endocervical and ectocervical margins and no adenocarcinoma in situ [AIS] or CIN II or
CIN III at the inked or cauterized margin; one repeat cone and ECC permitted)
- Patients are eligible for the study when a cone and ECC are performed prior to
pre-enrollment in the study, and pathologic eligibility criteria are met; the cone and
ECC must be performed within 12 weeks prior to pre-enrollment in the study; if the
cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria,
patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment
in order to meet pathologic eligibility criteria
- Patients must sign an approved informed consent document
- If patient is of childbearing potential, she must have a negative blood or urine
pregnancy test within 14 days of surgical treatment on study
- Imaging with positron emission tomography (PET) scan, computed tomography (CT) scan of
the abdomen and pelvis, and/or magnetic resonance imaging (MRI) of the abdomen and
pelvis must be performed and negative for metastatic disease within 12 weeks of
enrollment
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk
histologies
- Grade 3 adenocarcinoma
- FIGO stage IA1, IB2, II, III or IV disease
- Tumors > 2 cm in diameter on physical exam or imaging studies
- Presence of LVSI
- Greater than or equal to 10 mm of cervical stromal invasion
- Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or
adenocarcinoma-in-situ (one repeat cone permitted)
- Neoadjuvant radiation therapy or chemotherapy for cervical cancer
- Patients unwilling or unable to provide informed consent for the study
- Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of
enrollment
- Patients who have had a simple hysterectomy (cut through hysterectomy)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
137
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Recruitment in Australia
Recruitment state(s)
Parkvill
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Recruitment hospital [1]
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Royal Women's Hosptial - Victoria
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Recruitment postcode(s) [1]
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3052 - Victoria
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Nebraska
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Country [3]
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United States of America
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State/province [3]
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New Jersey
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Texas
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Country [6]
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Argentina
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State/province [6]
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Buenos Aires
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Country [7]
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Brazil
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State/province [7]
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Sao Paulo
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Country [8]
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Colombia
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State/province [8]
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Bogota
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Country [9]
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Mexico
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State/province [9]
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Tlalpan
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Country [10]
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Peru
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State/province [10]
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Lima
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Country [11]
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Thailand
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State/province [11]
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Pathumwan
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Funding & Sponsors
Primary sponsor type
Other
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Name
M.D. Anderson Cancer Center
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This clinical trial studies conservative surgery in treating patients with low-risk stage IA2
or IB1 cervical cancer. Conservative surgery is a less invasive type of surgery for early
stage cervical cancer and may have fewer side effects and improve recovery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01048853
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kathleen M Schmeler
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Address
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M.D. Anderson Cancer Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01048853
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